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Lidocaine hydrochloride

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Active ingredient
Lidocaine Hydrochloride 20 mg/1 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2012
Label revision date
February 7, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 20 mg/1 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2012
Label revision date
February 7, 2024
Manufacturer
Safetec of America, Inc.
Registration number
M017
NDC root
61010-5000
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (6 NDCs)
Packaging & NDC Codes (6)

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

Burn Gel is a product designed to provide temporary pain relief for minor burns. It can help soothe discomfort and promote healing for those who have experienced minor skin injuries due to heat. This gel is easy to apply and is intended for use on small burn areas to help you feel more comfortable as your skin recovers.

Uses

If you’re dealing with minor burns, this medication can provide temporary relief from the pain. It’s designed to help soothe discomfort, allowing you to feel more comfortable as you heal.

Rest assured, this medication does not have any known teratogenic effects, meaning it does not cause birth defects. You can use it with confidence, knowing it’s safe in that regard.

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply this medication to the affected area up to four times a day. Make sure to follow this guideline to ensure safe and effective use.

However, if your child is under 2 years old, it’s important not to use this medication without first consulting a doctor. Always prioritize safety and seek professional advice when it comes to younger children.

What to Avoid

It's important to use this medication safely to avoid potential harm. You should not use it in large quantities, especially on raw or blistered areas of your skin, as this can lead to irritation or other complications. Additionally, be very careful to keep it away from your eyes; if it accidentally comes into contact with them, rinse your eyes thoroughly with water to prevent any damage.

Always follow these guidelines to ensure your safety and the effectiveness of the treatment. If you have any questions or concerns about how to use this medication properly, don't hesitate to reach out to your healthcare provider for guidance.

Side Effects

This product is intended for external use only. It's important to avoid using it in large amounts, especially on raw or blistered skin, and to keep it away from your eyes. If the product accidentally gets into your eyes, rinse them thoroughly with water.

You should stop using the product and consult your doctor if your condition worsens, persists for more than seven days, or if it clears up and then returns within a few days. Additionally, keep this product out of reach of children. If swallowed, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is for external use only, so please avoid using it on large areas of your skin, especially over raw or blistered spots. Be careful not to apply it near your eyes; if it does get in your eyes, rinse them thoroughly with water.

If your condition worsens, does not improve after 7 days, or clears up only to return within a few days, stop using the product and consult your doctor. Additionally, if you accidentally swallow any of the product, seek emergency medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room. Acting quickly can make a significant difference in the outcome.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and seek assistance if you suspect an overdose.

Pregnancy Use

It is important to be cautious if you are pregnant or planning to become pregnant. The safety of this medication during pregnancy has not been established, which means that there is not enough information to confirm that it is safe for you or your developing baby.

Due to potential risks to the fetus, it is generally not recommended to use this medication while pregnant. If you have any questions or concerns about your health and medication use during pregnancy, be sure to discuss them with your healthcare provider.

Lactation Use

If you are breastfeeding and considering the use of lidocaine hydrochloride gel, you can feel reassured that there are no specific warnings or recommendations regarding its use for nursing mothers. The information available does not indicate any concerns about the gel being passed into breast milk or any associated risks for your infant.

As always, it's a good idea to consult with your healthcare provider if you have any questions or concerns about using medications while breastfeeding. They can provide personalized advice based on your situation.

Pediatric Use

When using this medication for children, it's important to follow specific guidelines. For children aged 2 years and older, you can apply it to the affected area up to four times a day. However, if your child is under 2 years old, you should not use this medication without first consulting a doctor. Always prioritize your child's safety and seek professional advice if you're unsure.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always ensure that your healthcare provider is aware of your age and any existing health conditions, as they can provide personalized advice and monitor for any potential issues. Your safety and well-being are the top priority.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not change based on liver function. However, it’s always a good idea to discuss your liver health with your healthcare provider before starting any new medication. They can help ensure that your treatment is safe and effective for you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share all the medications and supplements you are using. This way, you can work together to ensure your treatment is safe and effective.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and keep it away from direct light. It's important not to freeze the product, as this can affect its effectiveness. After opening, remember to discard any unused portion to maintain safety and quality. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

You should apply this medication topically to the affected area, up to four times a day, if you are an adult or a child aged 2 years and older. If the patient is under 2 years old, it's important to consult a doctor before use. There are no additional details available regarding laboratory tests, abuse potential, or postmarketing experiences related to this medication.

FAQ

What is Burn Gel used for?

Burn Gel is used for temporary pain relief for minor burns.

Who can use Burn Gel?

Adults and children 2 years and older can use Burn Gel. Children under 2 should not use it and should consult a doctor.

How often can I apply Burn Gel?

You can apply Burn Gel to the affected area not more than 4 times daily.

Are there any warnings for using Burn Gel?

Yes, it is for external use only. Do not use in large quantities, particularly over raw or blistered areas, and avoid contact with eyes.

What should I do if I accidentally swallow Burn Gel?

If swallowed, get medical help or contact a Poison Control Center right away.

What should I do if my condition worsens or does not improve?

Stop using Burn Gel and ask a doctor if your condition worsens or persists for more than 7 days.

Is Burn Gel safe to use during pregnancy?

The safety of Burn Gel during pregnancy has not been established, and its use is not recommended due to potential risks to the fetus.

How should I store Burn Gel?

Store Burn Gel at room temperature, protect it from light, and do not freeze. Discard any unused portion after opening.

Packaging Info

Below are the non-prescription pack sizes of Lidocaine Hydrochloride. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Lidocaine Hydrochloride.
Details

Drug Information (PDF)

This file contains official product information for Lidocaine Hydrochloride, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Safetec Burn Gel is indicated for the temporary relief of pain associated with minor burns. Each unit contains 0.125 oz. (3.7 ml) of the gel formulation. The product is identified by the National Drug Code (NDC) 61010-5000-0 and is available for reorder under number 50000. It is manufactured by Safetec of America, Inc., located in Buffalo, NY 14215. For further information, the manufacturer can be contacted at 800-456-7077 or through their website at www.safetec.com.

Uses and Indications

This drug is indicated for the temporary relief of pain associated with minor burns.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children aged 2 years and older, the medication should be applied to the affected area no more than four times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under the age of 2 years, the use of this medication is not recommended. Healthcare professionals should advise caregivers to consult a doctor for appropriate alternatives or further guidance.

Contraindications

Use is contraindicated in the following situations:

Application in large quantities, particularly over raw or blistered areas, is not recommended due to the potential for exacerbating skin irritation or damage. Additionally, the product should not be applied near the eyes; in the event of contact, it is essential to rinse thoroughly with water to prevent irritation or injury.

Warnings and Precautions

For external use only. This product should not be applied in large quantities, particularly over raw or blistered areas. Care should be taken to avoid contact with the eyes; in the event of accidental exposure, it is imperative to rinse the eyes thoroughly with water.

Healthcare professionals should advise patients to discontinue use and seek medical advice if the condition worsens, persists for more than 7 days, or if the condition clears up and then recurs within a few days.

In cases of ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Side Effects

For external use only. Patients are advised not to use the product in large quantities, particularly over raw or blistered areas, and to avoid contact with the eyes. In the event of accidental contact with the eyes, it is recommended to rinse thoroughly with water.

Patients should discontinue use and consult a healthcare professional if the condition worsens or persists for more than 7 days, or if the condition clears up and then recurs within a few days.

It is important to keep the product out of reach of children. In case of ingestion, medical assistance should be sought immediately, or contact a Poison Control Center without delay.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Lidocaine Hydrochloride. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Lidocaine Hydrochloride.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area up to four times daily. For children under 2 years of age, the use of this medication is not recommended without consulting a healthcare professional.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in this population.

Pregnancy

Safety during pregnancy has not been established for this medication. Use is not recommended during pregnancy due to potential risks to the fetus. Healthcare professionals should consider alternative treatments for pregnant patients to avoid any adverse fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception while using this medication.

Lactation

There are no specific warnings or recommendations regarding the use of lidocaine hydrochloride gel in lactating mothers. Additionally, there is no information available concerning the potential for excretion of lidocaine hydrochloride in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

There is no available information regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with liver problems.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients that in the event of accidental ingestion, it is crucial to seek medical assistance immediately or contact a Poison Control Center. This prompt action is essential to ensure the safety and well-being of the patient.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from light exposure. Freezing the product is not permitted, as it may compromise its integrity. After opening, any unused portion must be discarded to maintain safety and efficacy.

Additional Clinical Information

The product is administered topically, with a recommended application frequency of up to four times daily for adults and children aged 2 years and older. For children under 2 years of age, it is advised to consult a doctor before use. No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Lidocaine Hydrochloride, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Lidocaine Hydrochloride, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update:

Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.